{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-11920", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220530", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20210914", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220530", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1598831", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220530", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380430-03", "catalog_number": "380430", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874113028", "udi_public": "(01)00886874113028", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220530", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "70 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Ulcer", "Pressure Sore/Ulcer", "Post Operative Wound Infection", "Ulcer", "Pressure Sore/Ulcer", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20210921", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14541416", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210921", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "293280040", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT OR ALLEGATION FROM THE SURGEON OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A SYSTEM ERROR LOG REVIEW FOR THE PROCEDURE ON (B)(6) 2021 WAS CONDUCTED AND THERE WERE NO OBSERVED EVENTS OR ENTRIES IN THE SYSTEM LOGS AFTER THE PROCEDURE BEGAN. THERE IS NOTHING WOULD INDICATE OR SUGGEST A PRODUCT ISSUE. THREE PHOTOS WERE PROVIDED FOR EVALUATION AND AN ISI CLINICAL DEVELOPMENT ENGINEER¿S (CDE) OBSERVATIONS ARE AS FOLLOWS: REGARDING PERSPECTIVE ON THE AREA ABOVE THE UMBILICUS - THE SI CAMERA ARM HAS TWO FINS WHICH GRASP THE THIRD PARTY ENDOSCOPE CANNULA. MOVEMENT OF THE CAMERA ARM THROUGHOUT THE PROCEDURE COULD CONCEIVABLY RESULT IN INTERACTION OF THE FINS WITH THE PATIENT BODY. THE TWO MARKINGS SHOWN ARE CONSISTENT WITH POSITION OF THE FINS ON THE SYSTEM. FROM A CLINICAL PERSPECTIVE, REGARDING THE PORT PLACEMENT / SYSTEM SET-UP ¿ IN RELATION TO THE REPORTED EVENT, AND FROM THE LIMITED VIEW WE HAVE, PORT PLACEMENT APPEARS NORMAL AND WITHIN OUR RECOMMENDED GUIDELINES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE PATIENT INCURRED TISSUE DAMAGE BY THE UMBILICUS AS A RESULT OF MECHANICAL TRAUMA FROM EITHER A CANNULA OR OTHER INSTRUMENT/ACCESSORY USED DURING THE PROCEDURE. ANTIBIOTIC OINTMENT WAS ADMINISTERED DUE TO THE TISSUE INJURY THE SURGEON SUSPECTED WAS A POSSIBLE \"PRESSURE ULCER.\" BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "293280041", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, A PATIENT HAD REACHED OUT TO THE SURGEON; STATING A POST-OPERATIVE ¿BURN ON HIS UMBILICUS¿ WAS IDENTIFIED. PHOTOGRAPHS OF THE AFFECTED AREA WERE SUPPLIED TO THE SURGEON BY THE PATIENT. THE IMAGES DEPICTED A ¿PRESSURE ULCER,¿ WHICH THE SURGEON INDICATED WERE FROM A 3RD PARTY 12MM DISPOSABLE CANNULA DURING THE COURSE OF THE PROCEDURE, THE CANNULA MAY HAVE BEEN RUBBING UP AGAINST THE PATIENT POSSIBLY CAUSING THE ULCER. THE SURGEON BELIEVES THAT THE PRESSURE OF THE INDIVIDUAL AND THE CANNULA MAY HAVE CAUSED THIS. THE INITIAL DA VINCI PROCEDURE WAS COMPLETED WITH NO KNOWN OR REPORTED INJURY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: THE SURGEON STATED THAT, ¿BELOW THE UMBILICUS IS JUST THE CLOSED PORT SITE WITH STERI-STRIPS AND DRIED BLOOD,¿ AND THAT ¿THE CRESCENT SHAPED RED AREAS¿ ABOVE THE UMBILICUS IS WHERE THE ARM PROBABLY PUSHED DOWN AND CAUSED THE PRESSURE ON A ¿DISPOSABLE 10/12 THIRD PARTY TROCAR BY ETHICON.¿ THE SURGEON SAID THAT IT APPEARS TO BE AN ABDOMINAL ¿PRESSURE ULCER.¿ THE SURGEON INDICATED THAT, ¿THE TROCAR CAN PUSH ON THE ABDOMEN AND CAUSE A PRESSURE SORE AND THAT THE PRESSURE FROM THE TROCAR CAN ¿MAKE AN INDENTATION.¿ THE SURGEON SAID HE BELIEVED THAT IT WAS A PRESSURE ULCER AS OPPOSED TO A BURN BECAUSE THE NURSE WHO CARED FOR THE PATIENT RIGHT AFTER SURGERY AND A DAY LATER STATED SHE DID NOT SEE ANYTHING BUT THEN ¿THE NEXT DAY OR THE DAY AFTER,¿ SHE SAW THE AFFECTED AREA AND, IT LOOKED LIKE A TAPE BURN. THE SURGEON SAID THAT THESE ¿PRESSURE SITUATIONS USUALLY SHOW UP LATER.¿ NO MEDICAL INTERVENTION, OTHER THAN ¿NEOSPORIN¿ HAS BEEN ADMINISTERED AND THAT THE PATIENT IS ¿DOING JUST FINE.¿ THE SURGEON BELIEVES THAT DURING THE COURSE OF THE TWO-HOUR PROCEDURE, THE CANNULA MAY HAVE BEEN RUBBING UP AGAINST THE PATIENT, WHERE THE ARM CONNECTS TO THE TROCAR, POSSIBLY CAUSING THE ULCER THAT PRESENTED APPROXIMATELY TWO DAYS POST-OPERATIVELY. WHEN ASKING ABOUT THE THICKNESS OF THE PATIENT¿S ABDOMINAL WALL AND WAS THERE ANYTHING UNUSUAL, THE SURGEON SAID \"NO.\" THE SURGEON SAID THAT THERE WERE NO SYSTEM OR INSTRUMENT ISSUES DURING THE INITIAL PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }